Regulatory Affairs Specialist

Cure Talent; Uxbridge; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

A rapidly growing medical device company in Uxbridge is seeking a Regulatory Affairs Specialist to join their Quality & Regulatory team. This hybrid role includes maintaining regulatory documentation and ensuring compliance with various standards like UKCA and FDA. The ideal candidate will have proven experience in Regulatory Affairs within the medical device industry, strong knowledge of ISO 13485, and excellent organizational skills. If you're looking for an opportunity to grow with a dynamic business, we want to hear from you.

Qualifications

• Proven Regulatory Affairs experience in the medical device industry.
• Strong knowledge of ISO 13485.
• Logical, proactive problem-solving skills.
• Excellent report writing and time management skills.
• Ability to work cross-functionally.

Responsibilities

• Support and maintain the company’s Quality Management System (QMS).
• Write, review, and maintain technical files and regulatory documentation.
• Ensure compliance with relevant standards such as UKCA, EU MDR, and FDA.
• Manage document control and update procedures.
• Support product development and UDI processes.

Skills

Regulatory Affairs experience

Knowledge of ISO 13485

Problem-solving skills

Attention to detail

Report writing skills

Organisational skills

Interpersonal skills

Education

Science-based degree or equivalent

Job description

Cure Talent are delighted to be partnered with a rapidly growing medical device company with a diverse portfolio spanning IV therapy, diabetes care, surgical, anaesthesia, sexual health and more. As the business continues to expand, we have an exciting opportunity for a Regulatory Affairs Specialist to join their dedicated Quality & Regulatory team.

This is a hybrid role with the expectation of being on site in Uxbridge once a week.

As the new Regulatory Affairs Specialist, you will play a vital role in supporting all Quality and Regulatory activities across the business. You will contribute to the development and maintenance of regulatory documentation, ensure compliance with global standards, and support smooth implementation of evolving regulations, while working closely with internal teams and external stakeholders.

Key Responsibilities

• Support and maintain the company’s Quality Management System (QMS).
• Write, review, and maintain technical files and other regulatory documentation (MDD, MDR, IVDR, UKCA, FDA, Procedure Packs).
• Ensure compliance with UKCA, EU MDR, FDA and relevant ISO standards.
• Manage document control, updating procedures and product fact sheets.
• Support product development and UDI processes.
• Coordinate and support internal and external audits.
• Monitor regulatory and standards updates, ensuring timely implementation.

Experience and Skills Required

• Proven Regulatory Affairs experience within the medical device industry, across a range of device classes.
• Strong knowledge of ISO 13485.
• Science-based degree or equivalent.
• Logical, proactive problem-solving skills with strong attention to detail.
• Excellent report writing, organisational and time management skills.
• Strong interpersonal skills with the ability to work cross-functionally.
• Multi-language skills would be an advantage.

If you’re a Regulatory Affairs professional seeking an exciting opportunity to support a broad medical device portfolio and grow with a dynamic business, we’d love to hear from you.